ResApp Health Submitted De Novo Application to the FDA For ResAppDx-US

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ResApp Health Submitted De Novo Application to the FDA For ResAppDx-US

 ResApp Health Submitted De Novo Application to the FDA For ResAppDx-US

A leading digital health company, ResApp Health Limited (ASX: RAP) has submitted an application to the US Food and Drug Administration (FDA) for De Novo classification of ResAppDx-US. ResAppDx-US is a mobile software application used by clinicians as an aid in the diagnosis of primary upper respiratory tract disease lower respiratory tract disease and asthma/reactive airway disease.

The company believes that this software application can improve diagnostic accuracy, shorten time to treatment and improve access to diagnostic testing, all using only a smartphone. Currently, this technology is not for Sale in the United States.

With the submission of the application, the company is preparing for the commercial launch of ResAppDx-US. The De Novo application is supported by the SMARTCOUGH-C-2 clinical study which recruited over 1,400 patients at three hospital sites in the US. Further, this application is representing the culmination of years of development work and marks a significant milestone towards commercialization.

This technology will be a great help to clinicians as it will provide substantial clinical benefits by providing actionable information.

The company has been focusing on the treatment of respiratory diseases which is a major portion of healthcare concerns in children. As per the company’s CEO Tony Keating, most people will develop an acute respiratory infection every year and these infections are the most common acute illnesses dealt with in primary care. According to him, primary care is under pressure globally, with government, healthcare payers and providers looking for technology-led solutions, such as telehealth, to deliver more convenient, accurate and cost-effective healthcare. Acute respiratory disease diagnosis is a complex, subjective process, combining clinical judgement with diagnostic aids such as auscultation with a stethoscope, chest x-ray, blood and sputum tests.

The company’s sleep apnoea program is also taking shape with first proof of concept results for screening obstructive sleep apnoea in April 2018 and its first prospective set of results in October 2018. Obstructive sleep apnoea is a serious medical condition in which breathing is repetitively interrupted during sleep due to partial or complete upper airway blockage. The company is excited by the clinical and commercial potential that a software application running on a smartphone placed on a bedside table is offering in screening large portions of the population easily and at low cost.

At the time of writing, i.e., on 15 April 2019 AEST 2:15 PM, the stock of the company was trading at a price of $0.120 during the day’s trade with the market capitalisation of ~$94.43 Mn. The counter opened at $1.125 which was also the day’s high and touched the day’s low of $0.120 with daily volume of ~530,965. In the past six months, the share price of the company decreased by 40.0% as on 12 April 2019. It has 52 weeks high of $0.280 and 52 weeks low of $0.069 with an average volume of ~672,271.


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